Determining when a clinical activity should be classified as research requiring institutional review board review

Ernest D. Prentice, Bruce Geoffrey Gordon, Melody H. Lin

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

The boundary between therapy and research may at times be difficult to distinguish, and it is, therefore, important for health care professionals to recognize when a clinical activity should be properly classified as research. Research may be subject to federal regulations which require advance review and approval by an Institutional Review Board (IRB) in order to protect the rights and welfare of patients who serve as human subjects. This paper will discuss the criteria health care professionals can use to distinguish between therapy, innovative therapy, and therapeutic or clinical research.

Original languageEnglish (US)
Pages (from-to)88-91
Number of pages4
JournalJournal of Extra-Corporeal Technology
Volume29
Issue number2
StatePublished - Jun 1 1997

Fingerprint

Research Ethics Committees
Research
Delivery of Health Care
Investigational Therapies
Patient Rights
Therapeutics

Keywords

  • Federal regulations
  • Human subjects
  • Institutional Review Board
  • Research

ASJC Scopus subject areas

  • Medicine (miscellaneous)

Cite this

Determining when a clinical activity should be classified as research requiring institutional review board review. / Prentice, Ernest D.; Gordon, Bruce Geoffrey; Lin, Melody H.

In: Journal of Extra-Corporeal Technology, Vol. 29, No. 2, 01.06.1997, p. 88-91.

Research output: Contribution to journalArticle

@article{67956203966a47329f45da7cc2a5cc66,
title = "Determining when a clinical activity should be classified as research requiring institutional review board review",
abstract = "The boundary between therapy and research may at times be difficult to distinguish, and it is, therefore, important for health care professionals to recognize when a clinical activity should be properly classified as research. Research may be subject to federal regulations which require advance review and approval by an Institutional Review Board (IRB) in order to protect the rights and welfare of patients who serve as human subjects. This paper will discuss the criteria health care professionals can use to distinguish between therapy, innovative therapy, and therapeutic or clinical research.",
keywords = "Federal regulations, Human subjects, Institutional Review Board, Research",
author = "Prentice, {Ernest D.} and Gordon, {Bruce Geoffrey} and Lin, {Melody H.}",
year = "1997",
month = "6",
day = "1",
language = "English (US)",
volume = "29",
pages = "88--91",
journal = "Journal of Extra-Corporeal Technology",
issn = "0022-1058",
publisher = "American Society of Extra-Corporeal Technology",
number = "2",

}

TY - JOUR

T1 - Determining when a clinical activity should be classified as research requiring institutional review board review

AU - Prentice, Ernest D.

AU - Gordon, Bruce Geoffrey

AU - Lin, Melody H.

PY - 1997/6/1

Y1 - 1997/6/1

N2 - The boundary between therapy and research may at times be difficult to distinguish, and it is, therefore, important for health care professionals to recognize when a clinical activity should be properly classified as research. Research may be subject to federal regulations which require advance review and approval by an Institutional Review Board (IRB) in order to protect the rights and welfare of patients who serve as human subjects. This paper will discuss the criteria health care professionals can use to distinguish between therapy, innovative therapy, and therapeutic or clinical research.

AB - The boundary between therapy and research may at times be difficult to distinguish, and it is, therefore, important for health care professionals to recognize when a clinical activity should be properly classified as research. Research may be subject to federal regulations which require advance review and approval by an Institutional Review Board (IRB) in order to protect the rights and welfare of patients who serve as human subjects. This paper will discuss the criteria health care professionals can use to distinguish between therapy, innovative therapy, and therapeutic or clinical research.

KW - Federal regulations

KW - Human subjects

KW - Institutional Review Board

KW - Research

UR - http://www.scopus.com/inward/record.url?scp=0030738708&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0030738708&partnerID=8YFLogxK

M3 - Article

VL - 29

SP - 88

EP - 91

JO - Journal of Extra-Corporeal Technology

JF - Journal of Extra-Corporeal Technology

SN - 0022-1058

IS - 2

ER -